Status:
WITHDRAWN
SCOPE: Strategies to Combine PrEP With Prevention Efforts
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Family Health Options Kenya
Gilead Sciences
Conditions:
HIV
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This pilot, open-label, prospective study will determine the feasibility of integrating pre-exposure prophylaxis (PrEP) into existing HIV prevention programs for female sex workers and if women who ar...
Detailed Description
Participants will undergo the following procedures: blood draw for HIV (screening, enrollment, month 1, quarterly follow-up visits and final) and creatinine testing (screening, month 3 and final) and ...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Willing and able (i.e., successfully complete an open-ended comprehension assessment on key topics related to the study) to give written informed consent
- Expresses willingness at screening and enrollment to take PrEP daily
- Willing to provide contact information and be contacted by staff between visits (per participant-approved methods)
- Is sexually active, defined as having had at least one vaginal sex act in the last four weeks, and reports receiving money or goods in exchange for sex in the last 6 months as part of her source of income/livelihood
- Is HIV antibody negative on rapid test algorithm at the enrollment visit
- Does not have symptoms suggestive of acute HIV infection at the enrollment visit (i.e., fever (temperature above 38ºC), fatigue, sweating, night sweats, pain, rash, pharyngitis, headache, muscle and joint pain, adenopathy (cervical and inguinal), vomiting, diarrhea and coughing) combined with self-reported possibility of recent HIV exposure leading to clinical suspicion of acute HIV infection
- Has a negative urine pregnancy test at screening and enrollment
- Is not currently trying to become pregnant
- Is not breastfeeding
- Has a creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula) at screening
- Is Hepatitis B virus antigen (HBV Ag) negative at screening
- Is in general good health and does not have a medical or social condition which may make study participation unsafe or complicate data interpretation in the opinion of the site investigator
- Is not participating in another PrEP program or PrEP research study
- Is not taking HIV post-exposure prophylaxis at enrollment
Exclusion
- Pregnant HIV antibody positive Using HIV post-exposure prophylaxis at enrollment
- \-
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01832571
Start Date
June 1 2013
End Date
July 1 2013
Last Update
July 15 2013
Active Locations (2)
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1
Family Health Options Kenya
Eldoret, Kenya
2
Sex Workers Outreach Programme (SWOP)
Nairobi, Kenya